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FDA's MedWatch Safety Alerts: August 2009

continued...

Quick-set infusion sets made by Medtronic Inc. that are used with MiniMed Paradigm insulin pumps have been recalled because the infusion sets may not allow the insulin pump to vent air pressure properly. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a person with diabetes.

Affected infusion sets have lot numbers starting with the number “8” and have one of these reference numbers:

  • MMT-396
  • MMT-397
  • MMT-398
  • MMT-399

The lot number (for example, 8XXXXXX) is clearly marked on both the product box label and on each individual infusion set package.

The risk: The infusion set may deliver too much or too little insulin and may lead to serious injury or death.

Recommendations

  • Stop using “Lot 8” Quick-set infusion sets.
  • Return any affected infusion sets to the company, which will replace them at no additional charge. For more information, see Medtronic's Web page or call Medtronic at 800-345-8139.

 

Recall: Stealth Chocolate and Stealth Vanilla Powdered Dietary Supplement

The powdered dietary supplement, Stealth Chocolate and Stealth Vanilla, has been recalled because it may be contaminated with the bacteria Salmonella. The product, made by Vital Pharmaceuticals Inc., was distributed nationwide, including GNC Distribution Centers and the VPX Sports Distribution Center, as well as internationally.

The powdered product is packaged in 5-pound blue plastic jars with a red band around the top and bottom of the jar. The label bears the brand name of VPX and STEALTH, Muscle Amplification Lean Mass Gainer, and the flavor Vanilla Blast or Chocolate Rush.

The risk: Salmonella can cause serious infections and even death in young children, frail or elderly people, and others with weakened immune systems.

Recommendations

  • Return the product to the store where you bought it for a refund.
  • Call Vital Pharmaceutical Inc. at 800-954-7904 or 954-641-0570 for more information.

 

Recall: Nuby Gel Filled, Cottontails, and Playschool Teethers

Certain teethers made by Luv N’ Care LTD have been recalled because they may contain harmful bacteria in the gel contained in the teether. The teethers affected have the following UPC codes and brand names:

48526-00451 Nuby

48526-00452 Nuby

48526-00453 Nuby

48526-00454 Nuby

48526-00455 Nuby

48526-00459 Nuby

48526-00467 Nuby

48526-00472 Nuby

48526-00473 Nuby

48526-00482 Nuby

48526-00483 Nuby

48526-00487 Nuby

48526-00490 Nuby

48526-00519 Nuby

48526-00521 Nuby

41520-87115 Cottontails

50428-91511 Playschool

41520-91660 Cottontails

The teethers were sold through retail stores nationwide and also on the Internet. They are packaged in a plastic bubble on a printed card.

The risk: The bacteria (Bacillus subtilis and Bacillus circulans) that have been found on the teethers can cause stomach pain, vomiting, and diarrhea in children with weakened immune systems if the teether is punctured and the liquid from the teether is swallowed.

Recommendations

  • Stop using the teethers immediately.
  • Throw the teethers out or return them to the store where you bought them for a refund.
  • Contact Luv N’ Care LTD at 1-800-256-2399 ext. 3106 for more information.

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